Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: EvasayilTM : A Placebo-controlled Trial to Evaluate the Efficacy and Safety of Spesolimab in the Treatment of Patients With Netherton Syndrome
Brief Summary:
This study is open to people with a skin disease called Netherton syndrome (NS).
People can join the study if they are 12 years and older.
The purpose of this study is to find out whether a medicine called spesolimab helps people with NS.
Participants are divided into a spesolimab and a placebo group.
Placebo injections look like spesolimab injections but do not contain any medicine.
Every participant has a 2 in 3 chance of being in the spesolimab group.
In the beginning, participants get the study medicine as an injection into a vein.
Afterwards, they get it as an injection under the skin every month.
After 4 months, participants in the placebo group switch to spesolimab treatment.
Participants are in the study for about 1 year.
During this time, they visit the study site 16 times.
Where possible, 4 of 16 visits can be done at the participant's home instead of the study site.
The doctors regularly check participants' NS symptoms.
The results are compared between the groups to see whether spesolimab works.
The doctors also regularly check participants' general health and take note of any unwanted effects.